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NCT01756248

EYLEA Age-Related Macular Degeneration (AMD) Post-marketing Surveillance in Japan

Completed Last updated 7 June 2023
What this trial tests

trial testing Aflibercept(Eylea, VEGF Trap-Eye, BAY86-5321) in Macular Degeneration in 3,872 participants. Completed in 20 May 2019.

Timeline
26 December 2012
Primary endpoint
31 December 2018
20 May 2019

Quick facts

Lead sponsorBayer
StatusCompleted
Study typeOBSERVATIONAL
Enrollment3,872
Start date26 December 2012
Primary completion31 December 2018
Estimated completion20 May 2019
Sites1 location across Japan

Drugs / interventions tested

Conditions studied

Sponsor

Bayer — full company profile →

Who can join

Eligibility, any sex, with Macular Degeneration. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received EYLEA for Age-Related Macular Degeneration (AMD). The objective of this study is to assess safety and effectiveness of EYLEA using in real clinical practice. A total of 4,000 patients are to be enrolled and assessed in 3 years standard observational period. An annual follow-up survey will be conducted for 5 years at the longest after standard observational period.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Long-term surveillance provides real-world evidences of safety and effectiveness in intravitreal aflibercept treatment for age-related macular degeneration.
    Ozawa Y, Ohgami K, Sasaki K, Hirano K, et al · · 2023 · cited 4× · PMID 37391547 · DOI 10.1038/s41598-023-37584-1

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Other recruiting trials for Macular Degeneration

Currently open trials in the same condition.

Other Bayer trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01756248.

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